David J Kennedy1, Joshua Levin2, Richard Rosenquist3, Virtaj Singh4, Clark Smith5, Milan P Stojanovic6, Yakov Vorobeychik7. 1. Department of Orthopaedics, Stanford University Redwood City, CA. 2. Department of Orthopaedics and Neurosurgery, Stanford University, Palo Alto, CA. 3. Department of Pain Management, Cleveland Clinic, Cleveland, OH. 4. Department of Rehabilitation Medicine, University of Washington, Seattle, WA. 5. Department of Rehabilitation and Regenerative Medicine, Columbia University, New York, NY. 6. Department of Anesthesiology, Critical Care and Pain Medicine Service, VA Boston Healthcare System, Boston, MA. 7. Departments of Anesthesiology and Neurology, Penn State Hershey Medical Center, Hershey, Pennsylvania.
Abstract
BACKGROUND: In April 2014, the Food and Drug Administration (FDA) issued a Drug Safety Communication requesting that corticosteroid labeling include warnings that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death. RESULTS: The International Spine Intervention Society spearheaded a collaboration of more than a dozen other medical societies in submitting the letter below to the FDA on November 7, 2014. We are publishing the letter to ensure that the readership of Pain Medicine is aware of the multisociety support for the safety and effectiveness of these procedures. A special note of thanks to all of the societies who signed on in support of the message. Wiley Periodicals, Inc.
BACKGROUND: In April 2014, the Food and Drug Administration (FDA) issued a Drug Safety Communication requesting that corticosteroid labeling include warnings that injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death. RESULTS: The International Spine Intervention Society spearheaded a collaboration of more than a dozen other medical societies in submitting the letter below to the FDA on November 7, 2014. We are publishing the letter to ensure that the readership of Pain Medicine is aware of the multisociety support for the safety and effectiveness of these procedures. A special note of thanks to all of the societies who signed on in support of the message. Wiley Periodicals, Inc.